CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Neural stem cells loaded with an oncolytic adenovirusbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03072134
NCT03072134Phase 1Completed

Neural Stem Cell Oncolytic Adenoviral Virotherapy of Newly Diagnosed Malignant Glioma

Northwestern University·interventional·Posted Mar 7, 2017·Updated Jan 20, 2023

In Brief

A Phase 1 clinical trial evaluating Neural stem cells loaded with an oncolytic adenovirus for Glioma and 7 related conditions. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diagnosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.

Study Details

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 7, 2017
Enrollment StartApr 24, 2017
Primary CompletionApr 6, 2020
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.3 years ago

Interventions

Neural stem cells loaded with an oncolytic adenovirusbiological

The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.